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Ligament decompression tool with tissue removal deviceRelated Patent Categories: Surgery, Instruments, Cutting, Puncturing Or PiercingLigament decompression tool with tissue removal device description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060235452, Ligament decompression tool with tissue removal device. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation of PCT application Serial No. PCT/US2005/027216 filed Jul. 29, 2005, and entitled "Spinal Ligament Modification Devices", which claims benefit of U.S. application Ser. No. 60/592,099 filed Jul. 29, 2004, and entitled "Device for Percutaneous Treatment of Spinal Stenosis," which is incorporated herein by reference in its entirety. TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to a minimally invasive method, device and system for treating spinal disorders using imaging guidance. This invention also relates to devices used to reduce stenosis and increase the cross-sectional area of the spinal canal and to devices used to treat excess fat within the spinal canal or epidural lipomatosis. This invention also relates to methods, devices, therapies and medications used to treat disorders that involve the epidural space. BACKGROUND OF THE INVENTION [0003] The spine comprises a stack of vertebrae with an intervertebral disc between adjacent vertebrae. As shown in FIG. 1, each vertebra 10 includes a vertebral body 12 that supports a bony ring 14. The bony ring 14 consists of laminae 16, spinous process 18, transverse processes 20, superior articular processes 22, and pedicles 24. Together with vertebral body 12, these vertebral components define the spinal canal. The laminae 16 are joined in the midline by the spinous process 18. In the cervical and thoracic region the dural sac 32 contains the spinal cord, which comprises nerves 34 surrounded by cerebrospinal fluid. The fluid-filled sac is therefore compressible. The ligamentum flavum 26 is an elastic yellow ligament connecting the laminae of adjacent vertebrae. [0004] In degenerative conditions of the spine, narrowing of the spinal canal (stenosis) can occur. Lumbar spinal stenosis is often defined as a dural sac cross-sectional area less than 100 mm2 or an anteroposterior (AP) dimension of the canal of less than 10-12 mm for an average male. [0005] The source of most cases of lumbar spinal stenosis is thickening of the ligamentum flavum. Spinal stenosis may also be caused by subluxation, facet joint hypertrophy, osteophyte formation, underdevelopment of spinal canal, spondylosis deformans, degenerative intervertebral discs, degenerative spondylolisthesis, degenerative arthritis, ossification of the vertebral accessory ligaments and the like. A less common cause of spinal stenosis, which usually affects patients with morbid obesity or patients on oral corticosteroids, is excess fat in the epidural space. The excessive epidural fat compresses the dural sac, nerve roots and blood vessels contained therein and resulting in back and leg pain and weakness and numbness of the legs. Spinal stenosis may also affect the cervical and, less commonly, the thoracic spine. [0006] Patients suffering from spinal stenosis are typically first treated with exercise therapy, analgesics and anti-inflammatory medications. These conservative treatment options frequently fail. If symptoms are severe, surgery is required to decompress the canal and nerve roots [0007] To correct stenosis in the lumbar region, an incision is made in the back and the muscles and supporting structures are stripped away from the spine, exposing the posterior aspect of the vertebral column. The thickened ligamentum flavum is then exposed by removal of the bony arch (lamina) covering the back of the spinal canal (laminectomy). The thickened ligament can then be excised with sharp dissection with a scalpel or punching instruments such as a Kerison punch that is used to remove small chips of tissue. The procedure is performed under general anesthesia. Patients are usually admitted to the hospital for approximately five to seven days depending on the age and overall condition of the patient. Patients usually require between six weeks and three months to recover from the procedure. Many patients need extended therapy at a rehabilitation facility to regain enough mobility to live independently. [0008] Much of the pain and disability after an open laminectomy is due to the tearing and cutting of the back muscles, blood vessels and supporting ligaments and nerves that occurs during the exposure of the spinal column. Also, because these spine stabilizing back muscles and ligaments are stripped and cut off, the spine these patients frequently develop spinal instability post-operatively, [0009] Minimally invasive techniques result in less post-operative pain and faster recovery compared to traditional open surgery. Percutaneous interventional spinal procedures can be performed with local anesthesia, thereby sparing the patient the risks and recovery time required with general anesthesia. Another advantage is that there is less damage to the paraspinal muscles and ligaments with minimally invasive techniques reducing pain and preserving these important stabilizing structures. [0010] Various techniques for minimally invasive treatment of the spine are known. Microdiscectomy is performed by making a small incision in the skin and deep tissues to create a portal to the spine. A microscope is then used to aid in the dissection of the adjacent structures prior to discectomy. The recovery for this procedure is much shorter than traditional open discectomies. Percutaneous discectomy devices with fluoroscopic guidance have been used successfully to treat disorders of the disc but not to treat spinal stenosis of the ligamentum flavum directly. Arthroscopy or direct visualization of the spinal structures using a catheter or optical system have also been proposed to treat disorders of the spine including spinal stenosis however these devices still use miniaturized standard surgical instruments and direct visualization of the spine similar to open surgical procedures. These devices and techniques are limited by the small size of the canal and these operations are difficult to perform and master. Also these procedures are painful and often require general anesthesia. The arthroscopy procedures are time consuming and the fiber optic systems are expensive to purchase and maintain. [0011] In addition, because the nerves of the spine pass through the core of the spine directly in front of the ligamentum flavum, any surgery, regardless of whether is open or percutaneous includes a risk of damage to those nerves. [0012] Hence, it remains desirable to provide a simple method and device for treating spinal stenosis and other spinal disorders without requiring open surgery. It is further desired to provide a system whereby the risk of damage to the thecal sac containing the spinal nerves can be reduced. SUMMARY OF THE INVENTION [0013] The present invention provides a method, device and system for treating spinal stenosis or other spinal disorders using image guidance in combination with percutaneous techniques. The present system is referred to as a minimally invasive ligament decompression (MILD) device. In some embodiments, the present invention provides a means for compressing the thecal sac within the epidural space so as to provide a safety zone in which further surgical procedures may be performed without risk of damaging nearby tissues or the thecal sac itself. [0014] In further embodiments, the present method comprises the steps of a) percutaneously accessing the epidural space in a region of interest with image guidance; b) at least partially compressing the thecal sac in the region of interest by injecting a fluid into the epidural space to form a safety zone; c) percutaneously accessing a working zone in at least one of the ligamentum flavum and overlying dorsal tissues with image guidance, where the safety zone lies between the working zone and thecal sac; d) inserting a tissue removal tool into the working zone; e) using the tool remove tissue so as to reduce the stenosis; and f) utilizing at least one imaging system to identify tissues for removal. By way of example, radiologic imaging may be used to safely guide the tool(s) to target tissues and visualize the position of the tool during at least part of the process. [0015] In preferred embodiments, the device provides an anchored pathway to the working zone so that excised tissue can be shuttled out of the area for successive extractions without time consuming repositioning of the tool(s). In other embodiments, the tool can be repositioned as often as is necessary to achieve the desired modifications. In still other embodiments, the present invention includes percutaneous methods for placing a retractable anchor in the ligamentum flavum and attaching it to the fascia or bone so as to retract the ligamentum flavum, thus expanding the spinal canal. In still other embodiments, the invention includes a percutaneous mechanical suture system and method for placing a stitch in the ligament and then anchoring the stitch so as to retract the ligamentum flavum. The laminotomy site can serve as a site for a bone anchor and/or flange for a suture to anchor the ligament. [0016] Particular embodiments of the invention include a method for treating stenosis in a spine, the spine including a thecal sac and a canal and an epidural space therebetween, wherein the stenosis determines a region of interest in the spine. The method may comprise the steps of a) percutaneously accessing the epidural space in the region of interest, b) compressing the thecal sac in the region of interest by injecting a fluid to form a safety zone and establish a working zone, with the safety zone lying between the working zone and the thecal sac, c) inserting a tissue removal tool into tissue in the working zone, d) using the tool to percutaneously reduce the stenosis. It is preferred to use at least one imaging system to visualize the position of the tool during at least a part of step d). [0017] Step d) may include 1) engaging adjacent tissue in the working zone, 2) excising the engaged tissue, 3) removing the resulting tissue section from the working zone, and 4) repeating steps 1) through 3) until a desired amount of tissue has been removed. The removed tissue may comprise a portion of the ligamentum flavum, fat, and/or bone. Alternatively, the step d) may include i) providing an anchor having first and second tissue-engaging ends, ii) engaging the ligamentum flavum with the first tissue-engaging end, iii) using the engaged first end to pull at least a portion of the ligamentum flavum into a desired position, and iv) using the second tissue-engaging end to anchor the anchor such that the ligamentum flavum is retained in a desired position. The anchor may be anchored to paraspinous tissue or to other bone. [0018] The invention also relates to an injectable fluid, which may include a contrast agent and may have a temperature-dependent viscosity such that it is more viscous at 37.degree. C. than at 30.degree. C. [0019] The tool of steps c) and d) may include an outer cannulated scalpel or needle, a tissue-engaging means, and a cutting or resecting element and may further include means for removing tissue from the tissue-engaging means. The tissue-engaging means may comprise a resilient hook. [0020] Some embodiments of the invention may take the form of a kit for performing a procedure on a spine, in which the kit includes an insertion member for accessing the epidural space, and an expandable device adapted to be inserted into the epidural space by the insertion member and expanded so as to compress a portion of the thecal sac and provide a safety zone within the epidural space. The expandable device may comprise a volume of a contrast medium, such as a radio-opaque non-ionic myelographic contrast medium, and/or may comprise a volume of a medium that is injectable at ambient temperatures and more viscous at body temperature. The contrast medium may include a bioactive agent and/or a steroid. Continue reading about Ligament decompression tool with tissue removal device... Full patent description for Ligament decompression tool with tissue removal device Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Ligament decompression tool with tissue removal device patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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